China NMPA Product Recall - oxygen concentrator

Philips (China) Investment Co., Ltd. has initiated a voluntary Class III recall of specific oxygen concentrators. This action, reported by the National Medical Products Administration (NMPA) on November 13, 2017, addresses a key regulatory compliance issue. The company failed to promptly update the Chinese labels on its oxygen concentrators after obtaining new product registration certificates, specifically for products registered under National Medical Device Registration Certificate No. 201. This oversight meant that essential updated product information was not accurately reflected on the labels in a timely manner. While no specific inspection dates are mentioned, the recall is a voluntary measure taken by Philips (China) under the regulatory oversight of the NMPA, which governs medical device registrations and post-market activities in China. As a required action, Philips (China) is recalling affected oxygen concentrators. Comprehensive details regarding the specific models, specifications, and batch numbers involved are provided in the "Medical Device Recall Event Report Form" to ensure all non-compliant units are addressed according to regulatory standards.